Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group II, Sindbus virus, and small molecule in the reply filed on 7/31/25 is acknowledged. The traversal is on the ground(s) that alphavirus capsid universally binds to IRAK1.
Applicant’s arguments are persuasive for the species election required for this elected group and both species elections are withdrawn.
Claims 1-6 and 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 9 is objected to because of the following informalities: Applicant should spell out Sindbus Virus the first time the abbreviation is used. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims require a 10% reduction. The claims require a standard or control to define the conditions the 10% is based on. The metes and bounds cannot be determined for the 10% without a specific control or reference.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims include portions of any IRAK1 protein and portions of any alphavirus capsid.
These portions must have the functions of binding to IRAK1, signaling from IRAK1, reducing infection and inhibiting innate immune response.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991).
In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of portions of any IRAK1 protein and portions of any alphavirus capsid. The specification does not disclose any portions of any IRAK1 protein and portions of any alphavirus capsid that is capable of functioning in the claimed methods.
The only written description supported whole alphavirus capsids of the species listed in claim 9. The only IRAK1 shown is the whole protein from HEK cells (human).
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe any portions of any IRAK1 protein and portions of any alphavirus capsid and thus does not satisfy either the Lilly nor Enzo standards. The specification does disclose portions of any IRAK1 protein and portions of any alphavirus capsid that function in the methods. The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of portions of any IRAK1 protein and portions of any alphavirus capsid that function. One of ordinary skill in the art would not be able to identify the broad claimed genus of portions of any IRAK1 protein and portions of any alphavirus capsid.
Thus, the specification does not provide an adequate written description of the genus of portions of any IRAK1 protein and portions of any alphavirus capsid that is required to practice the claimed invention. Applicants have not described the genus of portions of any IRAK1 protein and portions of any alphavirus capsid sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Claims 7-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for complete Sindbus capsid (as well as the other species listed in claim 9) and complete human IRAK1 that can function in the claimed methods, does not reasonably provide enablement for portions of the capsid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claims require portions of alphavirus capsid to that bind and have the IRAK1 interaction that inhibits infection by alphavirus.
The specification only teaches full length capsid.
There is no teaching of what portions have the function.
Landers et al. (Emerging Microbes & Infections 2024, VOL. 13, 2300452 (21 pages)) teach that not all fragments have the function of interacting with IRAK1 (Figure 1 B).
Thus, there is unpredictability in the portions that have the function to block infection of cells.
Thus, the lack of working examples, lack of guidance In the specification and the prior art, the unpredictability of the art of protein engineering and the great breadth of the claims greatly reduces the probability that one of skill In the art would successfully obtain the claimed invention without undue experimentation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13-16 are rejected under 35 U.S.C. 102a1 as being anticipated by Greenwood et al. (WO2014110114)
For claims 13 and 16, Greenwood et al. teach a method of screening for compounds that inhibit the innate immune system in an individual (activity of a compound utilized in this invention as an inhibitor of IRAK-1 ... may be assayed in vitro, in vivo or in a cell line .... in vitro assays quantitate the ability of the inhibitor to bind to IRAK-1, Para. [0163]; compounds and methods useful for inhibiting one or more interleukin-1 receptor-associated kinases, Para. [0002]; a composition of this invention is formulated for administration to a patient in need of such composition, para. [00144].
For claim 14, Greenwood et al. teach determining the signaling capability of the IRAK1 protein or the portion thereof in the presence of the text compound, wherein a compound that inhibits or reduces IRAK1-dependent signaling is indicative of a compound that inhibits the innate immune system in an individual (activity of a compound utilized in this invention as an inhibitor of IRAK-1, IRAK-2, and/or IRAK-4, or a mutant thereof, may be assayed in vitro, in vivo or in a cell line. In vitro assays include assays that determine inhibition of either the phosphorylation activity and/or the subsequent functional consequences, or ATPase activity of activated IRAK-1, Para. [0163].
For claim 15, Greenwood et al. teach small molecules to inhibit IRAK1 (claims 1 and 20 and para 0010).
Thus, Greenwood et al. anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671